Rivaroxaban Monotherapy vs Combination Therapy With Antiplatelets on Total Thrombotic and Bleeding Events in Atrial Fibrillation With Stable Coronary Artery Disease
Authors: Ryo Naito, Katsumi Miyauchi, Satoshi Yasuda, Koichi Kaikita, Masaharu Akao, Junya Ako, Tetsuya Matoba, Masato Nakamura, Nobuhisa Hagiwara, Kazuo Kimura, Atsushi Hirayama, Kunihiko Matsui, Hisao Ogawa, Akihiro Nakamura, Eiji Tamiya, Tadashi Yamamoto, Syuji Suetake, Teruo Noguchi, Shinichi Nakamura, Akihiko Matsumura, Jisho Kojima, Hiroshi Yamaguchi, Satoru Suwa, Takanori Yasu, Akihiro Nakajima, Takahisa Yamada, Hidekazu Arai, Yoshiki Hata, Toshihiko Sakanashi, Hironobu Tateishi, Toru Nakayama, Yoichi Nozaki, Yasuo Okumura, Masahide Tokue, Norihiro Kuroki, Yasuyuki Maruyama, Hiroshi Suzuki, Yasunori Nishida, Masazumi Ajioka, Kazuhiko Yumoto, Shogo Shimizu, Takahiko Aoyama, Hideki Shimomura, Terunori Takeda, Koichi Oshiro, Nobuyoshi Sugishita, Yoshisato Shibata, Takatoshi Otonari, Makoto Shimizu, Hajime Kihara, Hiroshi Ogawa, Atsuyuki Ono, Minoru Hazama, Kengo Tsukahara, Seichi Haruta, Tetsuya Haruna, Masaaki Ito, Kenji Fujii, Nobuhiko Atsuchi, Masataka Sata, Takatoshi Wakeyama, Naoyuki Hasebe, Yoshio Kobayasi, Kazuo Osato, Kiyoshi Hironaga, Yujiro Naganuma, Kazuhiro Anzaki, Shinya Okazaki, Yusuke Nakagawa, Keichi Tokuhiro, Koichi Tanaka, Tomoyasu Momose, Yusuke Fukushima, Ryosuke Kametani, Katsunori Kawamitsu, Yoshihiko Saito, Shintaro Akashi, Kenta Kumagai, Kenichi Eshima, Tetsuya Tobaru, Toshihiko Seo, Koichiro Okuhara, Ken Kozuma, Yuji Ikari, Toshiyuki Takahashi, Koji Oiwa, Ichiro Michishita, Hisanori Fujikura, Shinichi Momomura, Yoshihiro Yamamoto, Kenichiro Otomo, Taku Matsubara, Hideki Tashiro, Teruo Inoue, Masaharu Ishihara, Ichiro Shiojima, Eizo Tachibana, Kotaro Sumii, Nobuyasu Yamamoto, Nobuhiro Omura, Toshihiro Nakamura, Naohiko Takahashi, Yukiko Morita, Kouki Watanabe, Hiroyuki Fujinaga, Michiro Maruyama, Takefumi Oka, Takeshi Shirayama, Tetsuya Amano, Kazuki Fukui, Kenji Ando, Shuichi Oshima, Shuntaro Kagiyama, Hiroki Teragawa, Masaru Yuge, Shiro Ono, Tokushi Koga, Katsuhito Fujiu, Masanari Kuwabara, Yusuke Oya, Yoshihiro Yumoto, Naomitsu Kuji, Makoto Ikemura, Kazuomi Kario, Kenichi Chatani, Koji Sato, Hiroo Miyagi, Mikitaka Murakami, Katumi Saito, Masaaki Hoshiga, Shinji Sato, Norifumi Kubo, Yasuhiro Sakamoto, Kazuhiro Ashida, Hiroki Sakamoto, Saroshi Murasaki, Hiroki Uehara, Takashi Akasaka, Yurika Oba, Shiro Nakahara, Yoichi Hanaoka, Toshitaka Nishimiya, Ryusuke Tsunoda, Yoshito Onuma, Sadanobu Higuchi, Akihiro Tani, Atsuyuki Wada, Masashi Kato, Hiromi Obata, Yoshiharu Higuchi, Tsutomu Endo, Ritsushi Kato, Toshiro Matsunaga, Tosizo Matsuoka, Hiroo Noguchi, Makoto Usui, Takahiro Hayashi, Yutaka Otsuji, Takuya Osaki, Hirofumi Zaizen, Hirotaka Yoshihara, Kazushige Kadota, Toyoki Hirose, Takuya Miyazawa, Atsushi Mori, Masamitsu Takano, Wataru Shimizu, Minoru Wake, Seizo Oriso, Minoru Yoshiyama, Shigeo Kakinoki, Toshihiko Nishioka, Takefumi Ozaki, Kazumiki Nomoto, Kosaburo Seki, Kazuya Kawai, Yukio Ozaki, Shinichiro Miura, Masanori Kawasaki, Ryuichi Funada, Keigo Dote, Shinya Okamoto, Takayuki Owada, Tomohiro Doke, Toshiyuki Matsumura, Toshihiko Kubo, Masataka Horiuchi, Toshihiko Nagano, Atsushi Takaishi, Masaya Yamamoto, Hitoshi Nakashima, Yukichi Murozono, Mitsuru Munemasa, Yasushi Sakata, Naoto Inoue, Takehiro Ota, Yutaka Hamano, Norihiro Abe, Toshio Tsubokura, Masami Goto, Isao Kubota, Masafumi Yano, Ken Umetani, Taro Date, Hideo Morimoto, Toshiyuki Noda, Seiichi Goto, Kiyoshi Hibi, Akira Nakano, Shinya Hiramitsu, Yasuki Kihara, Masafumi Sugi, Nobuyuki Shiba, Daisuke Izumi, Tetsuya Sato, Kosuke Ajiki, Mitsuru Oishi, Michiro Kiryu, Tenei Ko, Hideyuki Ando, Syunichi Miyazaki, Toru Kinugawa, Hiromasa Otake, Hiroaki Kitaoka, Shinji Tayama, Yoshihiro Hirata, Soichi Honda, Mamoru Manita, Yasuhiro Ishii, Hiroyuki Oka, Yasuharu Nanba, Masami Nishino, Tomohiro Sakamoto, Toshihiko Saito, Hirosumi Sakai, Makoto Ichikawa, Shigeto Namiuchi, Toshiki Matsui, Kanichi Inoue, Nobuyuki Komiyama, Yoshihiro Akashi, Yuichi Nakamura, Tatsuya Komaru, Takeshi Hosokawa, Taishiro Chikamori, Hiroyuki Tanaka, Atsushi Suzuki, Osamu Arasaki, Kazutaka Aonuma, Yutaka Wakasa, Tomoharu Yoshizawa, Teruyasu Sugano, Naoto Yokota, Akiyoshi Kakutani, Tomohiro Suzuki, Yusei Abe, Toru Kataoka, Hideki Okayama, Hiroyoshi Yokoi, Keiichi Chin, Koichi Hasegawa, Hirofumi Tomita, Hirotsugu Honzyo, Hiroya Kawai, Kazuya Yamamoto, Yoshihiro Morino, Shuji Tsujiyama, Michihiro Yoshimura, Syuichi Hamasaki, Yawara Niijima, Takuma Aoyama, Yuji Mizuno, Akira Maki, Kengo Tanabe, Toyoaki Murohara, Tomoki Nakamura, Shojiro Naomi, Naoya Matsumoto, Tohru Minamino, Hiroshige Sairenji, Noriyuki Miyamoto, Masaya Arikawa, Hiroshi Ito, Yoshifusa Matsuura, Shiro Hata, Yusuke Nakatsu, Tomoya Onodera, Toru Kato, Hideo Amano, Eiichi Tokutake, Masafumi Kasao, Masahiko Moriguchi, Kazuhiro Yamamoto, Masazumi Tsuji, Hareaki Yamamoto, Yuzuru Yanbe, Takamasa Iwasawa, Makoto Suzuki, Hisao Mori
Journal: JAMA Cardiology (2022)

Appropriate regimens of antithrombotic therapy for patients with atrial fibrillation (AF) and coronary artery disease (CAD) have not yet been established.To compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in such patients.This was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label, randomized clinical trial. This multicenter analysis was conducted from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled. Data were analyzed from September 1, 2020, to March 26, 2021.Rivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy.The total incidence of thrombotic, bleeding, and fatal events was compared between the groups. Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.A total of 2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis. The total event rates for the rivaroxaban monotherapy group (1107 [50.0%]) and the combination-therapy group (1108 [50.0%]) were 12.2% (135 of 1107) and 19.2% (213 of 1108), respectively, during a median follow-up of 24.1 (IQR, 17.3-31.5) months. The mortality rate was 3.7% (41 of 1107) in the monotherapy group and 6.6% (73 of 1108) in the combination-therapy group. Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001). Monotherapy was an independent factor associated with a lower risk of subsequent events compared with combination therapy. The mortality risk after a bleeding event (monotherapy, 75% [6 of 8]; combination therapy, 62.1% [18 of 29]) was higher than that after a thrombotic event (monotherapy, 25% [2 of 8]; combination therapy, 37.9% [11 of 29]).Rivaroxaban monotherapy was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in these patients.ClinicalTrials.gov Identifier: NCT02642419.